Actively Recruiting
HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
Led by Institut Investigacio Sanitaria Pere Virgili · Updated on 2026-04-14
60
Participants Needed
1
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this non-randomized community clinical trial is to test how effective HIFEM (High Intensity Focused Electromagnetic) technology (BTL Emsella) is in strengthening pelvic floor muscles. The study focuses on first-time mothers who have recently given birth (postpartum) via vaginal delivery and are not showing symptoms of dysfunction. The main question this study aims to answer is: \- Can pelvic floor strength be restored after being exposed to weakening risk factors like pregnancy and childbirth? How to study works; The researcher will compare two groups of women to see how their muscles recover: 1. Those who receive the Emsella HIFEM treatment. 2. Those who follow their natural recovery without the treatment. Participant Journey: * Initial Check-up: Once the standard 6-week postpartum recovery period (quarantine) is over. * Eligibility: The researcher checks if participants meet the study criteria. * Decision: After receiving full information and signing a consent form, participants decide whether or not to undergo the treatment. * Final Results: A follow-up assessment is conducted 3 months after the first visit, regardless of whether the treatment was used.
CONDITIONS
Official Title
HIFEM in Pospartum (High Intensity Focused Electro-Magnetic Technology)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Primiparous women
- Vaginal delivery
- Singleton pregnancy
- Full-term pregnancy (over 37 weeks gestation)
- No symptoms related to pelvic floor muscle weakening, such as incontinence or prolapse
- Between 6 and 12 weeks postpartum (post-quarantine period)
You will not qualify if you...
- Presence of implanted devices such as pacemakers, defibrillators, or neurostimulators
- Electronic implants
- Drug delivery pumps like insulin or medication infusion pumps
- Metallic implants
- Intrauterine devices containing metal
- Application over growth plate area
- Severe or life-threatening disorders
- Pulmonary insufficiency
- Cardiac disorders
- Decompensated hemorrhagic conditions
- Decompensated blood coagulation disorders
- Malignant tumors
- Fever
- Epilepsy
- Currently menstruating
- Pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Centro Procrear
Tarragona, TARRAGONA, Spain, 43002
Actively Recruiting
Research Team
L
LYS GARCIA VILAPLANA, Lead Researcher
CONTACT
C
CRISTINA REY REÑONES, DOCTORA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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